FDA Risk Communication Panel: Meet The Members
22 CommentsBy Ed Silverman // November 5th, 2007 // 11:21 am
As promised last June, the agency has created a new risk communication advisory panel to advise the agency about how to best communicate to the public about risks and benefits of the products it regulates. The idea, by the way, originated with the Institute of Medicine report last year that was highly critical of the FDA. Not surprisingly, there were a fair number of nominations - more than 240 altogether.
“Communicating effectively about the safety and effectiveness of drugs and other medical products is one of the central roles of FDA,†says Randy Lutter, the FDA’s deputy commissioner for policy. “We were in such strong agreement about the value of the Risk Communication Advisory Committee that we expanded its scope to address communication regarding all products regulated by the agency, including our food supply responsibilities.â€
The committee’s 15 voting members include independent experts and members of the public. In its statement, the agency says experts were chosen from the fields of risk communication, risk perception, decision analysis, communication, social marketing, health literacy, journalism, and behavioral and social sciences. Public members include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health care providers. For some meetings, one or more industry reps may be invited to participate in a nonvoting capacity.
You can see the roster here. Among the panel members is AnnaMaria DeSalva, who heads the healthcare and pharmaceuticals practice at Hill & Knowlton, which counts large drugmakers among its clients, and a medical contributor to ABC’s Good Morning America. Members have been assigned to serve for periods ranging from one to four years, so you’ll have to wait a few monhts before you can throw your hat in the ring. The FDA expects to hold the committee’s first meeting in the first quarter of 2008.
just a reader
Nice story.
Bill Vaughn is on the Panel too, but that didn’t seem to merit a story. What is your implication? That because Ms. DeSalva has worked for pharmaceuticals she is not going to be able to fairly help the FDA in its risk communications?
Looking at the roster, most everyone else seems to be from academia. Does that make them better at communicating risk than companies that need to do this?
Come on. Lighten up; not everything is a conspiracy that leads to world domination by big Pharma…
Ed Silverman
Dear Just,
No implication. No conspiracy until proven otherwise. As you pointed out, most are from academia or non-profits. I noted DeSalva’s work simply because she makes her living by working specifically with industry. And I also mentioned out Prerna Khanna, a doctor who contributes to ABC, which covers the industry. Interestingly, the listserv for the Association of Health Care Journalists - and I’m a member - carried a little debate at the time over whether a journalist belongs on the panel, which is why I mentioned Khanna. (No, I didn’t participate in that debate). Right or wrong, I expected such a mix since the June announcement, because the agency is looking for different views. Whether this group can provide enough diversity and insight remains to be seen. And I’m feeling quite light, thanks.
Cheers
ed at Pharmalot
Lisa Van S
Marielos L. Vega, B.S.N., RN
Health Communication
UMDNJ,Newark
Hmmmm, a Lilly apologist,…maybe!!
UMDNJ is not an organization thats been free of scandal.
Are their any conflicts of interest..Time will tell…
Lisa Van S
No disrespect to Mr. Vaughan, but wasnt it Consumer’s Union who touted a “BOGUS” car seat study.These Folks even referred to Paxil Study 329 on their website,They couldnt even report on that correctly.
As far as journalists are concerned, maybe they should have chosen CNN’s Anderson Cooper, you know the saying,”KEEPING THEM HONEST”
Reality
Lisa,
Do you have any evidence whatsoever that Vega is a Lilly apologist or has any conflicts of interest?
Lisa Van S
Reality,
Time will tell.If there are conflicts,the Journalists will find them, they can be a pretty feisty group you know.
Reality
Lisa,
Time may very well tell. However, I asked YOU a very specific question: do you have any evidence, or are you just randomly accusing someone you no nothing about?
It’s a very simple yes/no question. Either show some evidence or admit this is pure speculation with absolutely no foundation.
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Reality
Lisa,
Perhaps you’ve been busy, and that accounts for your lack of response, but I just want to make sure you see this, and I don’t think it’s too demanding of an answer:
When you posted your insinuation of Vega, did you actually know anything about that person at all that would lead you or anyone else to conclude that this person was a Lilly apologist or was otherwise in the pocket of Big Pharma?
Again, this is a simple yes or no question that specifically regards this person. If you’re going to make these accusations in a public forum, you should be big enough to take responsibility for them and provide the information to back it up.
Lisa Van S
Good Morning, Reality,
Busy,.. yes. My nephew, who is a U.S. Marine,who just returned safely from Iraq, and yes, somethings are more important than others.
Clearly, I have hit a nerve,…Have a personal interest in this person,and would you care to share?
Reality
Lisa,
Yes, you’ve hit a nerve, but I don’t have any personal interest and don’t know this person other than what I’ve looked up since you called her out.
My problem is that you are impugning someone’s reputation despite not knowing anything about her or having any evidence to back up your accusation, and are unwilling to admit that you’ve done that.
You come here clamoring about companies or scientists taking responsibility for their actions, yet you continually fail to hold yourself up to any similar standards. I’d like to see you exhibit–just once–that same responsibility and admit that you unjustly insinuated this person of being a shill for Lilly.
Lisa Van S
Reality,
FDA has listed Vega as:
Expertise:Health Communication
UMDNJ has her listed as a:
Research Nurse
Free speech is provided to us under the U.S. Constitution….”and I am sure that includes us the Freedom to ask questions”!!!
Individuals who have had no knoweledge as to my Religious beliefs…..Have called me a Scientologist,others have called me a Plaintiff Attorney sympathizer.And lets not forget the comments Like:
Resident nutball and
You need a man or need to change batteries
I have had Industry Investigaters descend upon my community to gather material on every aspect of my personal life.
Impugning Someones Reputation!!! GO TO HELL
Reality
Lisa,
Yes, there is free speech, but there is also responsibility and consequences for saying or writing things that are untrue (i.e., slander and libel). In fact, it wasn’t more than a week ago where you issued a thinly veiled threat to Ed that the Star Ledger, which owns Pharmalot, would be responsible for sexual harassment that occurred on this board. Where does libel stack up I wonder?
And did you really just tell me to go to hell? Have I ever called you names? Have I ever been anything but civil to you despite our differences?
Lisa Van S
Reality,
Had I used a question mark,instead of an exclamation point, would we be having this conversation? And, if there are Conflicts of interest, do we not have the right to know?
And who should be held to a higher standard, the Consumer, or the Industry and its researchers?
Yes,you have been civil.
Reality
Lisa,
I’m flabbergasted you don’t seem to understand why accusing someone of something that you have no proof of is wrong. It’s like you’re willfully ignoring this very simple fact.
Of course we have the right to know etc., that’s not the point. You’re just making wild allegations. Kind of like when people call you Scientologist or nutball.
How does this not make any sense to you?
So you acknowledge that I’ve been civil, but still feel it’s okay to tell me to go to hell? Are you pathologically unable to say something like, “I am sorry, I was wrong”?
Jane
Excuse me, but how the heck is saying “only time will tell” accusing someone of something? When I read the statement I took away “lets see what happens”. Give it a rest Reality. There is obviously something more than just that statement going on here.
Ken Thomas, RN
UMDNJ has a website and includes their research foundation. Their foundation accepts funding from companies and their charitable foundations such as B*D, J&J, Sanofi-Aventis, Merck, Schering Plough, Wyeth, Bayer, LEV Pharmaceuticals, Pfizer, GSK, Bard, etc. etc. They don’t list the “educational grants” given to researchers.
Reality
Jane…hmmmm…possible pedophile! Only time will tell!
Get it now?
I have no direct personal interest other than an attempt get people to be honest and not make reflexive defamatory statements about people they know nothing about.
Even if she turns out to be a shill, it doesn’t justify the baseless accusation in retrospect.
Donna
Hi Reality,
Kinda like what you did to Lisa??? If you go back to the (Scarlet Golf Shirt) post on Nov. 2nd and re-read you will see that Lisa only stated that Pharmalot has the ( ABILITY )to protect women from sexual harassment on their site and asked them to do so…How you see that as a thinly veiled threat toward’s Ed, Pharmalot, or the Star Ledger has got me stumped. So please be clear on your fact’s before commenting, the same as you are asking of the rest of us.
Outside the Box
I appreciate the importance of the conversation, but does anyone mind if I get back to the FDA issue?
This is the first step in a process that the law has identified (FDA Reauthorization). The process we are now seeing start to play out will result in the FDA using over 100 million patient records (not claims, records) to assess drug adverse events, interactions, and so forth - and use this panel to “communicate” the results, impact, implications and so forth to the general public (please read the bill if you haven’t seen this). The FDA has been given two years to identify the appropriate data handling and analytical approaches to use, but this is coming folks. I know EMRs are not that widely used yet - but the bill gives the FDA a mandate to go and get them.
Does anyone agree with me that this could result in a massive loss of control and influence as far as pharma is concerned, and the impact on drug approvals, reimbursement and prescribing could result in huge changes to the way in which we do business? It won’t all be negative, but given the industry reputation just now I don’t feel confident that it won’t all be positive either.
Lisa Van S
Reality,
“Reflexive Defamitory Statements about people they know nothing about”
What about Bob and others,do you condone their behaviour?… Or is it, alls well in the he man, Woman haters club!! As a former volunteer of the Women’s Crisis Center,..You will receive no apology from me!!!!
For years UMDNJ has been involved in scandolous behaviour, at NJ taxpayers expense.UMDNJ conducts numerous clinical trials that are funded by the Pharmaceutical Industry.And Lilly funds physician education(Partners for Psychiatry), All you have to do is google.
As a Law Abiding, Tax Paying Resident, here in the State of NJ,I Believe, gives me the right to ask questions. And If YOU dont like it, so be it.!!
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